McKiver, M.P. (Mihaela Popa)

Filtering

20231

Settings

Author search.filters.isAuthorOfPublication.3858dda4-812c-4152-9f6b-2b7ec9a7db1e

Search Results

Now showing 1 - 1 of 1
  • Thumbnail Image
    Elotuzumab plus pomalidomide and dexamethasone for relapsed/refractory multiple myeloma: final overall survival analysis from the randomized phase II ELOQUENT-3 trial
    (2023) McKiver, M.P. (Mihaela Popa); Moreau, P. (Philippe); Jou, Y.M. (Ying-Ming); Yao, D. (David); Das, P. (Prianka); Hori, M. (Mitsuo); Raab, M.S. (Marc S.); Takezako, N. (Naoki); Suzuki, K. (Kenshi); LeBlanc, R. (Richard); Dimopoulos, M.A. (Meletios A.); Dytfeld, D. (Dominik); Richardson, P.G. (Paul G.); Grosicki, S. (Sebastian); San-Miguel, J.F. (Jesús F.); Leleu, X. (Xavier)
    Purpose: In the phase II ELOQUENT-3 trial (ClinicalTrials.gov identifier: NCT02654132), elotuzumab combined with pomalidomide/dexamethasone (EPd) significantly improved progression-free survival (PFS) versus pomalidomide/dexamethasone (Pd) in patients with relapsed/refractory multiple myeloma (RRMM) previously treated with lenalidomide and a proteasome inhibitor (PI). Here, we present the final overall survival (OS) results. Methods: Patients with RRMM who had received ¿ 2 prior lines of therapy, with disease refractory to last therapy and either refractory or relapsed and refractory to lenalidomide and a PI were randomly assigned (1:1) to receive EPd or Pd. The primary end point was PFS per investigator assessment. ORR and OS were secondary end points planned to be tested hierarchically. Results: A total of 117 patients were randomly assigned to EPd (n = 60) and Pd (n = 57). Among treated patients (EPd 60, Pd 55), there were 37 (61.7%) deaths in the EPd group and 41 (74.5%) in the Pd group, most commonly because of disease progression (EPd 41.7%, Pd 49.1%). Median (95% CI) OS was significantly improved with EPd (29.8 [22.9 to 45.7] months) versus Pd (17.4 [13.8 to 27.7] months), with a hazard ratio of 0.59 (95% CI, 0.37 to 0.93; P = .0217). OS benefit with EPd was observed in most patient subgroups. The safety profile of EPd was consistent with prior reports with no new safety signals detected. Conclusion: EPd demonstrated a statistically significant improvement in OS versus Pd in patients with RRMM previously treated with lenalidomide and a PI who had disease refractory to last therapy. In this setting, ELOQUENT-3 is the first randomized study of a triplet regimen incorporating a monoclonal antibody and Pd to improve both PFS and OS significantly.